IRB

An Institutional Review Board (IRB) is a committee that reviews research involving human participants to protect their rights and welfare. In the United States, IRBs operate under regulations that govern human subjects research, including 45 CFR 46 and 21 CFR 56, and they are commonly required for institutions that receive federal funding or engage in federally regulated research. Similar bodies exist in other countries, often called Research Ethics Committees or Ethics Boards.

Purpose and scope: IRBs evaluate proposed studies for risk to participants, potential benefits, and participant safeguards. They require informed consent that is voluntary and documented, assess privacy protections and data security, and ensure equitable selection of subjects. They also monitor ongoing studies for adverse events and protocol deviations.

Process: Researchers submit a protocol to the IRB for review. Depending on risk, the IRB may grant exempt, expedited, or full board review. The board may request modifications, impose conditions, or disapprove. After approval, continuing review is typically required at least annually, and any changes to the protocol or unanticipated problems must be reported.

Membership and operations: An IRB generally includes scientists, at least one non-scientist, and an unaffiliated member to provide lay perspective. Members should have training in human subjects protections. The chair or designated administrator coordinates reviews, maintains records, and ensures regulatory compliance.

History and context: IRBs became widespread in the United States after the National Research Act of 1974, with the Belmont Report outlining core ethical principles: respect for persons, beneficence, and justice.